This was the first evaluation of the effects of LCZ696 on local and regional measures of aortic stiffness in subjects with mild to moderate hypertension and widened pulse pressure. The results of this exploratory study will help to understand the mechanism of action of LCZ696 and used to inform the design of future clinical studies with LCZ696 in subjects with cardiovascular diseases.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
115
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Erlangen, Germany
Novartis Investigative Site
Basel, Switzerland
Novartis Investigative Site
Glasgow, Scotland, United Kingdom
Change From Baseline in Ascending Aorta Distensibility at 52 Week
Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Ascending aorta distensibility was one of the 3 components for measuring local arota distensibility.
Time frame: Baseline, 52 weeks
Change From Baseline in Proximal Descending Aorta Distensibility at 52 Weeks
Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Proximal descending aorta distensibility was one of the 3 components for measuring local arota distensibility.
Time frame: Baseline, 52 weeks
Change From Baseline in Distal Descending Aorta Distensibility at 52 Weeks
Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Distal descending aorta distensibility was one of the 3 components for measuring local arota distensibility.
Time frame: Baseline, 52 weeks
Change From Baseline in Local Aortic Strain at 52 Weeks
Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic strain. Local aortic strain was measured by assessing ascending aorta strain, proximal descending aorta strain and distal descending aorta strain.
Time frame: Baseline, 52 weeks
Change From Baseline in Regional Aortic Pulse Wave Velocity at 52 Weeks
Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of regional aortic pulse wave velocity.
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placebo
If required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to treatment regimen
Time frame: Baseline, 52 weeks
Change From Baseline in Central Blood Pressure at 52 Weeks
Central blood pressure was determined by measuring central systolic blood pressure , diastolic blood pressure and pulse pressure.
Time frame: Baseline, 52 weeks
Change From Baseline in Augmentation Pressure at 52 Weeks
Augmentation pressure is the added pressure during systole due to wave reflection.
Time frame: Baseline, 52 weeks
Change From Baseline in Augmentation Index at 52 Weeks
Augmentation index (Alx) is the percentage of the central pulse pressure due to wave reflection.
Time frame: Baseline, 52 weeks
Change From Baseline in Carotid-femoral Pulse Wave Velocity at 52 Weeks
For pulse wave velocity calculation, the pressure waveform at the femoral site (using a partially inflated custom blood pressure cuff) and the carotid site (using hand -held applanation tonometry) were measured simultaneously. Pulse wave analysis was performed on the central aortic pressure waveform as derived from the brachial pressure waveform recorded in a partially-inflated blood pressure cuff around the upper arm.
Time frame: Baseline, 52 weeks
Number of Patients With Reported Adverse Events, Serious Adverse Events and Death
This outcome measure summarizes patients with any adverse events, serious adverse events and death.
Time frame: 12 weeks